# VALIDATION OF A MULTIPLEXED ASSAY FOR BLADDER CANCER DIAGNOSIS

> **NIH NIH R01** · CEDARS-SINAI MEDICAL CENTER · 2020 · $250,500

## Abstract

Gap in Knowledge: No accurate, non-invasive tests are currently available to rule in patients with hematuria
or a history of bladder cancer (BCa) who need an invasive cystoscopy to evaluate the presence of a bladder
tumor. Background: The most common presenting symptom in patients with BCa is hematuria. In two large
studies, ~11% of patients with hematuria were noted to harbor BCa. Published guidelines recommend these
patients to obtain voided urinary cytology (VUC), in addition to cystoscopic evaluation. Cystoscopy is an
invasive, uncomfortable and expensive procedure associated with side effects such as transient voiding
symptoms, hematuria, UTI, and stenosis of the urethra, whereas, VUC has limited sensitivity of 25-40% in
detecting BCa (specificity is >90%), especially for low-grade and low-stage tumors. While some commercially
available urine-based assays for the detection of BCa are available, many suffer from a reduction in assay
specificity compared to VUC (e.g., NMP-22 and BTA). Furthermore, as single markers, these assays,
including VUC have insufficient predictive power to be applied to the management of individual patients, and
importantly, these techniques are complex, and require skillful interpretation. Our current NIH/NCI R01
application is testing a multiplex electrochemoluminescent (MEC) immunoassay’s ability to detect our BCa-
associated diagnostic signature in voided urine samples from subjects with gross hematuria and subjects with
a history of BCa on tumor surveillance. Since the inception of the R01 application, we have developed and
validated a multiplex bead-based (MBB) immunoassay, which possesses improved operational characteristics
such as area under receiver operating characteristic, sensitivity and specificity (0.942: CI 0.8645 – 0.9627,
93% and 95%, respectively using MBB platform vs. 0.892: CI 0.850 - 0.934, 85% and 81%, respectively using
MEC platform). Because of the substantial improvement in the MBB assay, we seek to incorporate the
evaluation of the MBB assay into the current R01 grant, and therefore compare the MBB assay to the MEC
assay in this supplemental application. Hypothesis: The MBB assay is more sensitive and specific than the
MEC assay in detecting our BCa-associated diagnostic signature in voided urine samples. Methodology: As
with the MEC assay, we will perform the MBB assay in a CLIA-certified laboratory. We will then compare and
contrast the operational characteristics of the MBB and MEC assays in the current, large multi-center
prospective studies. Upon completion of the proposed work, we expect to show that the MBB assay is non-
inferior to the MEC assay in detecting our BCa signature. Therefore, MBB assay will be transitioned into the
laboratory and used for our subsequent studies with the ultimate goal of accelerating the pace of translation of
our NCI-supported methods/assays/technologies to the clinic, which is the premise of PAR-17-003.

## Key facts

- **NIH application ID:** 9974986
- **Project number:** 3R01CA198887-05S1A1
- **Recipient organization:** CEDARS-SINAI MEDICAL CENTER
- **Principal Investigator:** Charles J Rosser
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $250,500
- **Award type:** 3
- **Project period:** 2016-05-01 → 2022-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9974986

## Citation

> US National Institutes of Health, RePORTER application 9974986, VALIDATION OF A MULTIPLEXED ASSAY FOR BLADDER CANCER DIAGNOSIS (3R01CA198887-05S1A1). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9974986. Licensed CC0.

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